IMPORTANT SAFETY INFORMATION AND INDICATION

Cyanide poisoning may result from inhalation, ingestion, or dermal exposure. Prior to administration of CYANOKIT, smoke-inhalation victims should be assessed for: exposure to fire or smoke in an enclosed area; presence of soot around the mouth, nose, or oropharynx, and altered mental status. In addition to CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of any seizure activity.

Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Consideration should be given to use of alternative therapies, if available. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Allergic reactions including angioneurotic edema have also been reported in postmarketing experience.

Acute renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals have been reported following CYANOKIT therapy. Monitor renal function for 7 days following CYANOKIT therapy.

Substantial increases in blood pressure may occur following CYANOKIT therapy. Elevations in blood pressure (≥180 mmHg systolic or ≥110 mmHg diastolic) were observed in approximately 18% of healthy subjects receiving hydroxocobalamin 5 g and 28% of subjects receiving 10 g.

Usage may interfere with some clinical laboratory evaluations. Also, because of its deep red color, hydroxocobalamin may cause hemodialysis machines to shut down due to an erroneous detection of a "blood leak." This should be considered before hemodialysis is initiated in patients treated with hydroxocobalamin. Due to potential photosensitivity, patients should avoid direct sun until erythema resolves.

There are no adequate and well-controlled studies of CYANOKIT in pregnant women. CYANOKIT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness of CYANOKIT have not been established in pediatric patients.

The most common adverse reactions (>5%) included transient chromaturia, erythema, oxalate crystals in urine, rash (predominantly acneiform), increased blood pressure, nausea, headache, decreased lymphocyte percentage, and injection site reactions.

INDICATION

CYANOKIT (hydroxocobalamin for injection) 5 g for intravenous infusion is indicated for the treatment of known or suspected cyanide poisoning. If clinical suspicion of cyanide poisoning is high, CYANOKIT should be administered without delay.

Please see full Prescribing Information.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

In the United States, expert advice from a regional poison control center may be obtained by calling 1-800-222-1222.